The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function
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상태완료
스폰서
Cedars-Sinai Medical Center
임상 시험: NCT00973557
BioSeek: nct00973557
키워드
요약
The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels. The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in the pituitary gland.
Patients who have been treated with Bevacizumab for at least one month will be recruited to participate.
The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator) will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with all the information and background of the study and see if they have an interest in being consented.
If consented, there will be 2 blood draws for the research that is not part of their standard care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH, thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the administration of Bevacizumab and the second 5 ml blood draw will occur after the administration of the Bevacizumab. The investigators will then review the laboratory results. The blood tests are of the hormones of the pituitary gland to test pituitary function and see if there are any abnormalities with the secretions of the gland. Pituitary function abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood and comparing them to the normal reference ranges.
This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai Medical Center.
날짜
| 마지막 확인: | 01/31/2012 |
| 처음 제출: | 09/07/2009 |
| 제출 된 예상 등록: | 09/07/2009 |
| 처음 게시 됨: | 09/08/2009 |
| 제출 된 마지막 업데이트: | 02/05/2012 |
| 마지막 업데이트 게시: | 02/06/2012 |
| 실제 연구 시작 날짜: | 08/31/2009 |
| 예상 기본 완료 날짜: | 08/31/2011 |
| 예상 연구 완료 날짜: | 12/31/2011 |
상태 또는 질병
Colorectal Cancer
Lung Cancer
Breast Cancer
Glioblastoma
단계
-
팔 그룹
| 팔 | 개입 / 치료 |
|---|---|
| Taking Bevacizumab Patients who are currently being treated for cancer by the drug Bevacizumab. |
자격 기준
| 공부할 수있는 연령 | 18 Years 에 18 Years |
| 공부할 수있는 성별 | All |
| 샘플링 방법 | Non-Probability Sample |
| 건강한 자원 봉사자를 받아들입니다 | 예 |
| 기준 | Inclusion Criteria: - Patients with colorectal cancer, lung cancer, breast cancer, and glioblastoma patients that have been treated with Bevacizumab for at least 1 month - Adults (18 years of age or older) Exclusion Criteria: - Patients who are taking medications known to affect serum prolactin levels - Patients who are pregnant - Patients who have pituitary disease - Minors (Under the age of 18) |
결과
1 차 결과 측정
1. To determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. [6 weeks]
Patients will have their blood drawn before their first Bevacizumab infusion and then again 6 weeks later.
